BEUDAMED
    26 results · 23ms · Sources: EU EUDAMED, US FDA

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    VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Oticon

    FDA UDI
    Oticon A/S·05707131167286·AGPR, ITC P PB DIR L BE AGIL PRO

    EVOLUT R TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 16, 2025

    EVOLUT R TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 16, 2025

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·August 16, 2025

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964107948·Endo Carry-On Procedure Kit

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964104831·Endo Carry-On Procedure Kit

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·August 6, 2019

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·August 6, 2019

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·August 6, 2019

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·August 6, 2019

    JOSTRA ARTERIAL PERFUSION CANNULAE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HRH-63 HEAD ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    FILTERWIRE EZ¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SAN JOSE·Product code NFA·May 9, 2013

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code GZB·September 19, 2014

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 23, 2011

    Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

    FDA Enforcement
    Class II ·Terminated·Allergan Inc·July 29, 2015

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021